Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 135

Inclusion Criteria

Inclusion criteria for the screening phase:
1. Diagnosed with cystic fibrosis (genetic diagnosis and/or abnormal sweat
test and clinical phenotype of lung disease)
2. Age = 8 yrs and < 18 yrs
3. Body weight = 20 kg
4. Able to produce a sputum sample (spontaneous or induced sputum)
5. Informed Consent given
Inclusion criteria for the intervention phase:
1. Diagnosed with cystic fibrosis (genetic diagnosis and/or abnormal sweat
test and clinical phenotype of lung disease)
2. Age = 8 yrs and < 18 yrs
3. Body weight =20 kg
4. Presence of Aspergillus infection as defined for this study
5. Clinically stable condition without a significant change in lung function
(FEV1 +/- 10%) or significant worsening of respiratory symptoms over the
previous month
6. Able to perform lung function test (FEV1%)
7. Able to produce a sputum sample (spontaneous or induced sputum)
8. Informed Consent given
9. If female and of childbearing age must be using highly effective
contraception (and must agree to continue for 7 days after the last dose of
investigational medicinal product [IMP])1

Are the trial subjects under 18? yes
Number of subjects for this age range: 135
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria for the screening phase:
1. Non-CF lung disorder
2. Age < 8 yrs of age or =18 yrs of age
3. Body weight < 20 kg
4. Not able to provide sputum sample
5. Informed Consent not given

Exclusion criteria for the intervention phase:
1. Non-CF lung disorder
2. Age < 8 yrs or =18 yrs
3. Body weight < 20 kg
4. Not able to perform lung function test (FEV1%)
5. Unable to produce a sputum sample (spontaneous or induced sputum)
6. Clinically unstable condition with significant change in lung function or significant worsening of respiratory symptoms
7. Unable to tolerate oral medication
8. Known hypersensitivity to itraconazole or posaconazole, or it’s excipients.
9. On active transplant list or transplant recipient
10. Azole resistant Aspergillus sp. Cultured
11. Patients receiving terfenadine, ergot alkaloids, astemizole, cisapride, pimozide, halofantrine, quinidine, or HMG-CoA reductase inhibitors metabolised through CYP3A4 (eg. simvastatin, lovastatin, and atorvastatin)
12. Patients receiving omalizumab
13. Received systemic mould-active antifungals in the last month
14. Shortened or elongated QT interval
15. Cardiac failure
16. ALT = 200 U/L
17. AST = 225 U/L
18. Alkaline phosphatase = 460 U/L
19. Bilirubin = 50 umol/L
20. eGFR = 20 ml/min/1.73 m2 (calculated with the Schwartz formula)
21. Patients with known glucose-galactose malabsorption problems
22. Pregnancy2 or breastfeeding
23. Females of childbearing age who do not intend to use contraception measures.
24. Informed Consent not given

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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